Release Testing

LIGHTHOUSE knows that by the time you reach the release testing stage in your pharmaceutical products lifecycle, you need to be confident in the manufacturing process and final product quality.

LIGHTHOUSE equipment can be used in QC labs to perform final release tests. The non-destructive nature of the measurement allows test samples to be used for other testing purposes if desired and also means that, because the sample stays intact, there is lower risk for product cross contamination and sample disposal issues after analysis.

Lyo Moisture

LIGHTHOUSE systems for measuring lyophilized product residual product moisture content offer a rapid, non-destructive method that streamlines moisture analysis efforts and ensures the quality of finished product. Headspace water vapor levels measured inside of a freeze-dried vial have been directly correlated to Karl Fischer measurements of those same vials. Headspace water vapor measurements have also been directly correlated to the degradation of the API, which means that the stability of a dry product could be defined in terms of the water vapor pressure inside the sealed vial. The applications of headspace moisture analysis take advantage of the fact that it is straightforward to analyze the headspace moisture content of all vials in a statistically relevant sample set.

Headspace Oxygen

The non-destructive nature of the measurement saves quality control product samples that may be in limited supply and means the same samples can be used for other testing purposes if desired. It also means that the same sample could be followed for the full shelf life with time point measurements giving direct insight into the sample evolution over time.

TESTIMONIALS

"At Gilead we use Lighthouse’s FMS benchtop headspace moisture/pressure analyzer to nondestructively confirm the integrity of developmental and investigatory vials. We use their high speed VISTA platform at the production level to confirm that 100% of inspected product is integral before it ships."

Tark Bunch

Senior Research Scientist at Gilead Sciences, USA

"We are studying the correlation of headspace moisture and product moisture in lyophilized products to see if this can be a good predictor to find an atypical/moist vial in a lot population. The team at Lighthouse are very knowledgeable and have been very helpful getting us up and running."

Tark Bunch

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